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Azithromycin in Patients with CF and Culture Negative for Pseudomonas aeruginosa

Study Type:

Interventional

Intervention Category:

Anti-Infective

Study Sponsor:

Rose, Lynn

Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.

Study Phase:

3

Recruitment Status:

Trial Completed

Study Drug(s):

Azithromycin

Number of Participants Being Recruited:

300

Single / Multi-Center:

Multi-Center

STUDY BACKGROUND INFORMATION:

This clinical trial looked at the effects of azithromycin on children with CF who are not infected with P. aeruginosa. Azithromycin is currently recommended for people with CF, 6 years of age or older, who have P. aeruginosa in their sputum for at least one year. Three previous trials showed improvements in lung function and a decrease in pulmonary exacerbations with azithromycin use. This evidence has led to widespread use of this therapy for patients chronically infected with P. aeruginosa. This new trial aimed to find out whether azithromycin could provide benefits to CF patients who are not infected with P. aeruginosa, as it does for those infected with the bacterium.

ELIGIBILITY

Age:

6 Years - 18 Years

FEV1:

>= 50 Percent Predicted

P. aeruginosa status:

Negative

B. cepacia status:

Negative

Other Primary Eligibility Requirements:

Eligible subjects must be negative for P aeruginosa for one year prior to screening (documented by at least 2 negative cultures)

Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific
trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.

A total of 260 patients were randomized to receive either azithromycin (N=131) or placebo (N= 129). The researchers found that treatment with azithromycin for 24 weeks, compared with placebo, did not result in improved pulmonary function, as measured by the change in FEV1 (the volume of air that can be forced out in one second after taking a deep breath)

Secondary Efficacy:

Analyses of exploratory end points demonstrated that when compared with the placebo group, the azithromycin group had a 50 percent reduction in pulmonary exacerbations, 27 percent reduction in the initiation of new oral antibiotics (other than azithromycin), 1.3 lbs. weight gain, and 0.34-unit increase in body mass index. There were no differences in treatment groups in the use of intravenous or inhaled antibiotics or hospitalizations.

Safety:

Participants in the azithromycin group had no increased risk of adverse events, but had less cough and less productive cough compared with placebo participants.